Sintea Biotech, Inc.
Medical device manufacturer in Miami Beach, FL.
10510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K082679 | Laki Hand Fixation System, Model TFX.3X.06.XJEC · Special | 04/07/2009SE |
| K081631 | Sintea Biotech PLS Multi-Axial ScrewsMNH · Special | 07/18/2008SE |
| K072198 | X-Void, SpiderHRX · Traditional | 06/06/2008SE |
| K070181 | Sintea Biotech Dsc/Alf Spinal System, DSC.XX.T5.XX, ALF.XX.T5.XXMQP · Traditional | 04/18/2007SE |
| K060513 | Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.XKWP · Special | 03/10/2006SE |
| K043355 | Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…KWP · Special | 12/17/2004SE |
| K041989 | Sintea Biotech Anterior Plate System, Model ACP.XX.T5.XKWQ · Traditional | 09/16/2004SE |
| K031154 | Sintea Biotech Schanz Screw, Model Tfx.Ss.Xx.XJDW · Traditional | 06/24/2003SE |
| K020085 | Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XMNH · Traditional | 12/10/2002SE |
| K022065 | Sintea Biotech Traumafix System, Model TFX.00.00.XJEC · Traditional | 08/06/2002SE |